Betamethasone

Registered South African indications:

• Anti-inflammatory
• Immune-modulation
• Glucocorticoid-remediable hyperaldosteronism or other adrenocorticotropic hormone mediated hyperaldosteronism
• Hypocortisolism

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Systemic infections unless anti-infective therapy is employed

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly
• Recent myocardial infarction
• Hypothyroidism
• Myasthenia gravis
• Live vaccines
• Psychiatric history
• Prolonged use
• Abrupt withdrawal
• Osteoporosis
• Hypertension
• Congestive cardiac failure
• Diabetes mellitus
• History of tuberculosis
• Glaucoma
• Previous corticosteroid-induced myopathy
• Epilepsy
• Peptic ulceration

Forms avail. in SA and covered in this monograph: syr, tab

Short term treatment for inflammatory conditions

• Oral (tab): Initial 2-3mg, dly for a few days; Then reduce dose by 0.25-0.5mg every 2-5 days depending on response
• Oral (syr): 0.6-4.8mg, dly

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See link: General prescribing points for steroids

See link: Choice of steroids for endocrine indications

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Specific doses based on individual indications:

Hypocortisolism secondary to primary or secondary adrenal insufficiency

• Oral (tab): 0.75mg, dly in the morning

Glucocorticoid-remediable hyperaldosteronism or other forms of adrenocorticotropic hormone mediated hyperaldosteronism

• Oral (tab): 0.125-0.250mg, dly at night; Titrate according to clinical response

Low-dose overnight suppression test for diagnosis of cortisol excess

• Oral (tab): 1mg, given at 23h00; Cortisol sampling done the following morning after breakfast

Prolonged low dose suppression test  for differentiation of pseudo-cushings from true cortisol excess

• Oral (tab): 0.5mg, 6hrly for 2 days; 24hr urinary cortisol and morning cortisol values obtained on both days

High dose overnight suppression test for differentiation of pituitary vs extrapituitary source of adrenocorticotropic hormone excess

• Oral (tab): 8mg, given at 23h00; Cortisol sampled morning before and morning after betamethasone dose

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This test is preferred to a prolonged high dose suppression test

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Hayfever

• Oral (tab): Initial: 1.5-2.5mg, dly

Inflammatory eye conditions - posterior segment

• Oral (tab): Initial: 2.5-4.5mg, dly

Rheumatoid arthritis

• Oral (tab): Initial: 0.5-2mg, dly

Acute rheumatic fever

• Oral (tab): Initial: 6-8mg, dly

Status asthmaticus

• Oral (tab): Initial: 3.5-4.5mg, dly for 1-2 days

Pulmonary emphysema and fibrosis

• Oral (tab): Initial: 2-3.5mg, dly

Bursitis

• Oral (tab): 1-2.5mg, dly

Disseminated lupus erythematous

• Oral (tab): Initial: 0.5-1mg, 12hrly for a few days

Dermatological conditions

• Oral (tab): Initial: 2.5-4.5mg, dly

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Administer daily dose early in the morning

Paed. forms avail. in SA and covered in this monograph: syr, tab

Congenital adrenal hyperplasia
Hypercalcaemia associated with cancer
Primary and secondary adrenocortical insufficiency

• Oral (syr, tab): 0.02-0.3mg/kg/day, in 3-4 divided doses depending on severity

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See link: General prescribing points for steroids

Pregnancy

• Caution
• The ability of corticosteroids to cross the placenta varies between individual agents, however, betamethasone readily crosses the placenta. Administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate, intra-uterine growth retardation and effects on brain growth and development. There is no evidence that corticosteroids result in an increased incidence of congenital abnormalities, such as cleft palate/lip in man. However, when administered for prolonged periods or repeatedly during pregnancy, corticosteroids may increase the risk of intra-uterine growth retardation. Hypoadrenalism may, in theory, occur in the neonate following prenatal exposure to corticosteroids but usually resolves spontaneously following birth and is rarely clinically important. Myocardial hypertrophy and gastroesophageal reflux have been reported in association with in-utero exposure to betamethasone
•  As with all agents, corticosteroids should only be prescribed when the benefits to the mother and child outweigh the risks. When corticosteroids are essential, however, patients with normal pregnancies may be treated as though they were in the non-gravid state. Patients with pre-eclampsia or fluid retention require close monitoring. Betamethasone, systemically administered to a woman during pregnancy may result in a transient suppression of the foetal heart rate parameters and biophysical activities that are widely used for the assessment of foetal well – being. These characteristics can include a reduction in foetal breathing movements, body movements and heart rate

Breastfeeding

• Caution
• Corticosteroids may pass into breast milk, although no data are available for betamethasone. Infants of mothers taking high doses of systemic corticosteroids for prolonged periods may have a degree of adrenal suppression

Renal Impairment

• Caution; no dose adjustment recommended

Hepatic Impairment

• Caution; no dose adjustment recommended

Elderly

• Caution; no dose adjustment recommended
  Lowest effective dose should be used

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Prohibited - In competition

Central Nervous System Disorders

• Malaise
• Psychotic reactions
• Behavioral disturbances
• Irritability
• Anxiety
• Sleep disturbances
• Cognitive dysfunction
• Confusion
• Amnesia
• Aggravation of epilepsy
• Increased intracranial pressure
• Psychological dependence

Cardiovascular Disorders

• Hypertension
• Myocardial rupture following recent myocardial infarction
• Thromboembolism

Gastrointestinal Disorders

• Abdominal distension
• Oesophageal ulceration
• Nausea
• Dyspepsia
• Peptic ulceration 
• Peptic ulcer perforation and haemorrhage
• Acute pancreatitis
• Candidiasis

Endocrine and Metabolic Disorders

• Sodium and water retention
• Hypokalaemia
• Suppression of hypothalamic-adrenal axis
• Growth suppression (children)
• Menstrual irregularity
• Cushingoid facies
• Hirsutism
• Increased weight
• Impaired glucose tolerance
• Negative protein, nitrogen and calcium balance
• Increased appetite
• Hyperhydrosis
• Increased high-density lipoprotein and low-density lipoprotein concentrations
• Withdrawal syndrome

Musculoskeletal Disorders

• Osteoporosis
• Vertebral fractures
• Long bone fractures
• Avascular osteonecrosis
• Tendon rupture
• Proximal myopathy

Skin and Subcutaneous Tissue Disorders

• Impaired healing
• Skin atrophy
• Bruising
• Telangiectasia
• Striae
• Acne
• Stevens-Johnson syndrome

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity
• Anaphylaxis
• Leukocytosis
• Increased susceptibility to infections 
• Opportunistic infections

Sensory Disorders

• Increased intra-ocular pressure
• Glaucoma
• Papilloedema
• Posterior subcapsular cataracts
• Corneal or scleral thinning
• Exacerbation of ophthalmic viral or fungal diseases

• Anticholinesterases
• Cholecystographic X-ray media
• Non-steroidal anti-inflammatory drugs
• Rifampicin
• Rifabutin
• Carbamazepine
• Phenobarbitone
• Phenytoin
• Primidone
• Aminoglutethimide
• Ephedrine
• Antidiabetic agents
• Antihypertensives
• Agents causing hypokalaemia
• Warfarin
• Salicylates
• Cardiac glycosides
• Ritonavir
• Oral contraceptives
• Neuromuscular blocking agents
• Fluoroquinolones
• Quetiapine
• Tretinion
• Somatropin
• Mifepristone
• Theophylline
• CYP34A inhibitors

None routine. Specific cases may require

• Blood glucose
• Weight
• Height (children)

Betamethasone exerts its action via lipocortins, phospholipase A2 inhibitory proteins which, through inhibition arachidonic acid, control the biosynthesis of prostaglandins and leukotrienes. The immune system is suppressed by corticosteroids due to a decrease in the function of the lymphatic system, a reduction in immunoglobulin and complement concentrations, the precipitation of lymphocytopenia, and interference with antigen-antibody binding.

Syrup (per 5ml) 0.6mg

• Betanoid (Pharmacare)
• Steromien (Pharmacare)

Tablet 0.5mg

• Betanoid (Pharmacare)
• Celestone (MSD) originator

Also available in the following forms: Cream, ointment, lotion, eye drop, nose drop and injection.